SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458

Immunoelectrophoretic, Immunoglobulins, (g, A, M)

HELENA LABORATORIES

The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Spife Ife-15 Pentavalent, Model 3456, Spife Ife-9 Pentavalent Kit, Model 3457, Spift Ife-6 Pentavalent Kit, Model 3458.

Pre-market Notification Details

Device IDK061069
510k NumberK061069
Device Name:SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458
ClassificationImmunoelectrophoretic, Immunoglobulins, (g, A, M)
Applicant HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont,  TX  77704
ContactPatricia Franks
CorrespondentPatricia Franks
HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont,  TX  77704
Product CodeCFF  
Subsequent Product CodeDEH
Subsequent Product CodeDFH
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-04-17
Decision Date2006-07-06
Summary:summary

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